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Sclerosis, MultipleNCT05857280

EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)

A study testing EXOPULSE Mollii Suit Stimulation in people with Sclerosis, Multiple and MS (Multiple Sclerosis), run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit stimulation in Multiple Sclerosis patients with spasticity. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
EXOPULSE Mollii Suit Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited Arab Emirates
Study dates
21 Mar 2023to 15 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
  • Age between 18 and 75 years.
  • Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) < 7).
  • Being free of relapses in the last three months.
  • Being able to understand verbal instructions.
  • Having spasticity with a score of at least 1+ on the MAS.
  • Having a BBS score ≤46 associated in the literature with a risk of fall.

Who cannot join

  • Being included in another research protocol during the study period.
  • Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
  • Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using EXOPULSE Mollii suit.
  • Being pregnant.
  • Having a change in their pharmacological therapy in the last three months.
  • Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
Show all 10Show fewer
  • Having a body mass index above 35 kg/m^2.
  • In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period.
  • Patients under juridical protection.
  • Prisoners.

Trial locations and contacts

1 site in 1 country.

Naji J Riachi, MD contact

+971 2 314 4444 ext. 2979

nriachi@ssmc.ae

Hasan M Jaber, Bsc contact

+971 2 314 4444 ext. 3869

hasjaber@ssmc.ae

United Arab Emirates1 site, 1 recruiting

  • SSMC

    Abu Dhabi

    Naji J Riachi, MD, +971 2 314 4444 ext. 2979, nriachi@ssmc.ae

    Hasan M Jaber, Bsc, +971 2 314 4444 ext. 3869, hasjaber@ssmc.ae

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP 2)

The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit stimulation in Multiple Sclerosis patients with spasticity. The main questions it aims to answer are:

  • to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult MS patients suffering from spasticity.
  • to assess the effects of EXOPULSE Mollii suit on mobility, upper and lower limbs muscle tone, pain, fatigue and quality of life.
Read more

Participants will participate in:

  • One baseline visit for inclusion during which the patient will undergo the first session (active or sham) along with evaluations (before and after the session)
  • One visit after two weeks during which the patient will undergo the second session (active or sham) along with evaluations (before and after the session)
  • One visit after two weeks of the second stimulation condition; the patients will undergo a third evaluation and receive the EXOPULSE Mollii Suit for the four-week open label phase and will use the suit at home for an active stimulation session every other day for four weeks.
  • One visit at the end of the open label phase to perform the fourth and last evaluation and return the EXOPULSE Mollii suit.

Researchers will compare both Active and Sham groups to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit.

Read the detailed description

The study is a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of motor functions and MS related symptoms following a single session of "active" versus "sham" EXOPULSE Mollii suit stimulation. in phase 1, the patient will receive two stimulations separated by a two-week washout period. The patients will be randomized to receive either active/sham or sham/active and both patients and investigators will be blinded to the order in which the stimulation will be given. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of phase 1, a second open label phase (phase 2) of this trial will be proposed to all patients where they will receive active stimulation every other day at home over four weeks (for a total of 14 sessions). This will help understand the long term effects of EXOPULSE Mollii suit stimulation on MS related symptoms.

Being tested
EXOPULSE Mollii Suit Stimulation
Medical subject headings
Multiple Sclerosis, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXOPULSE Mollii Suit StimulationDevice

    We designed a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of motor functions and MS related symptoms following a single session of "active" versus "sham" EXOPULSE Mollii suit stimulation. in phase 1, the patient will receive two stimulations separated by a two-week washout period. The patients will be randomized to receive either active/sham or sham/active and both patients and investigators will be blinded to the order in which the stimulation will be given. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of phase 1, a second open label phase (phase 2) of this trial will be proposed to all patients where they will receive active stimulation every other day at home over four weeks (for a total of 14 sessions). This will help understand the long term effects of EXOPULSE Mollii suit stimulation on MS related symptoms.

Study groups in NCT05857280
Study groupRoleWhat they receive
EXOPULSE Mollii Suit Stimulation ActiveActive comparatorThis will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes.
Receives: Device: EXOPULSE Mollii Suit Stimulation
EXOPULSE Mollii Suit Stimulation ShamSham comparatorThis will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes.
Receives: Device: EXOPULSE Mollii Suit Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance using Berg Balance Scale (BBS)

    Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

    Measured: To be assessed at baseline.

  2. Balance using Berg Balance Scale (BBS)

    Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

    Measured: To be assessed at week 2.

  3. Balance using Berg Balance Scale (BBS)

    Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

    Measured: To be assessed at week 4.

  4. Balance using Berg Balance Scale (BBS)

    Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with risk of fall across the literature.

    Measured: To be assessed at week 8.

Secondary outcomes (13)

  1. Visual Analog Score for spasticity.

    Spasticity will be measured using a visual analog score from 0 to 10, 0 being no spasticity and 10 being the worst possible spasticity.

    Measured: This to be assessed at baseline, then at week 2, week 4 and week 8.

  2. Mobility.

    Mobility will be evaluated by the 12-item Multiple Sclerosis Walking Scale (MSWS-12). Each one of the 12 items will be assessed and assigned numbers from 1 to 5, 1 being not at all to 5 being extremely common, and the results will be added to a total of 60, so the higher the score, the better the mobility.

    Measured: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

  3. Visual Analog Score for pain.

    Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain.

    Measured: This to be assessed at baseline, then at week 2, week 4 and week 8.

  4. Multiple Sclerosis International Quality of Life Questionnaire.

    Quality of life will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL). This questionnaire consists of 31 questions covering 9 domains including: 1- activity of daily living; 2- physical well-being; 3- relationships with friends; 4- symptoms; 5- relationships with family; 6- relationships with health care systems; 7- sentimental and sexual life; 8- coping; and 9- rejection. The questions are answered by ticking or checking the box that describes best of what patients would feel ranging from 0 to 4, 0 being not at all and 4 always or very much.

    For MusiQoL, the score of each of the nine sub domains is calculated as the average for the set of questions making up the domain. An overall score is then calculated as the average of all the scores for each subdomain. Prior to computing the final overall score, each domain-specific score is linearly transformed to a 0-100 scale with 0 being the worst quality of life and 100 the best.

    Measured: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

  5. Overall Clinical improvement.

    Evaluation of overall Clinical improvement will be done using the 7-point Clinical Global Impression (CGI). Patient will fill a questionnaire that will address their clinical situation as follows:

    1. Very much improved.
    2. Much improved.
    3. Slightly improved.
    4. No change.
    5. Slightly worse.
    6. Much worse.
    7. Very much worse.

    The score will range from 1-7, 1 being the best clinical outcome and 7 the worst.

    Measured: This to be assessed at baseline, then at week 2, and week 8.

  6. Blinding Questionnaire.

    Evaluation of patient's blinding to the type of stimulation in the crossover trial periods using a dedicated questionnaire. Patients will be asked whether they think they received the sham or active stimulation.

    No scale will be used for this measure.

    Measured: This to be assessed at baseline, then at week 2.

  7. Visual Analog Score for fatigue.

    Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue.

    Measured: This to be assessed at baseline, then at week 2, week 4 and week 8.

  8. Muscle tone.

    Muscle tone will be evaluated by the Modified Ashworth Scale (MAS). Scores will range from 0 to 4, 0 being no increase or normal muscle tone, to 4 being rigidity in flexion or extension of muscles.

    Measured: This to be assessed at baseline, then at week 2, week 4 and week 8.

  9. Fall Risk

    Fall risk will be assessed using the Falls Efficacy Scale-International scale. It is a 16-item scale, including a range of functional activities, that assesses the perceived risk of falling, using a score that will range from 1 to 4, 1 being not at all concerned to 4 being very concerned.

    Items are summed to a total score that will range from a minimum of 16 (no concern about falling) to a maximum of 64 (severe concern about falling).

    Measured: Two weeks after the second stimulation and 4 weeks later at the end of phase 2.

  10. Weight.

    The patient weight will be measured and recorded in kilograms.

    Measured: Baseline

  11. Height.

    The patient height will be measured and recorded in centimeters.

    Measured: Baseline

  12. Time Up and Go (TUG)

    Patients have to stand up from a chair when they hear the verbal instruction "go", walk a distance of 3 meters, turn around, walk back to the chair and sit down. Timing starts with the verbal instruction "go' and stops when the patients return to the seated position. The score consists of the time taken to complete the test activity, measured in seconds.

    Measured: Baseline, and through study completion

  13. Body Mass Index (BMI)

    The weight and height will be combined to report BMI in kg/m^2. BMI of 35 kg/m^2 or more will be used as an exclusion criterion for the study.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start21 Mar 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion15 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05857280
Sponsor's protocol ID
EXOSEP2
Status last verified
Apr 2024
First submitted
30 Mar 2023
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andringa A, van de Port I, van Wegen E, Ket J, Meskers C, Kwakkel G. Effectiveness of Botulinum Toxin Treatment for Upper Limb Spasticity Poststroke Over Different ICF Domains: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2019 Sep;100(9):1703-1725. doi: 10.1016/j.apmr.2019.01.016. Epub 2019 Feb 21.

    PubMed 30796921

  • Arroyo R, Massana M, Vila C. Correlation between spasticity and quality of life in patients with multiple sclerosis: the CANDLE study. Int J Neurosci. 2013 Dec;123(12):850-8. doi: 10.3109/00207454.2013.812084. Epub 2013 Jul 15.

    PubMed 23819835

  • Bakaniene I, Urbonaviciene G, Janaviciute K, Prasauskiene A. Effects of the Inerventions method on gross motor function in children with spastic cerebral palsy. Neurol Neurochir Pol. 2018 Sep-Oct;52(5):581-586. doi: 10.1016/j.pjnns.2018.07.003. Epub 2018 Jul 20.

    PubMed 30061001

  • Bar-On L, Molenaers G, Aertbelien E, Van Campenhout A, Feys H, Nuttin B, Desloovere K. Spasticity and its contribution to hypertonia in cerebral palsy. Biomed Res Int. 2015;2015:317047. doi: 10.1155/2015/317047. Epub 2015 Jan 11.

    PubMed 25649546

  • Baude M, Nielsen JB, Gracies JM. The neurophysiology of deforming spastic paresis: A revised taxonomy. Ann Phys Rehabil Med. 2019 Nov;62(6):426-430. doi: 10.1016/j.rehab.2018.10.004. Epub 2018 Nov 28.

    PubMed 30500361

  • Beard S, Hunn A, Wight J. Treatments for spasticity and pain in multiple sclerosis: a systematic review. Health Technol Assess. 2003;7(40):iii, ix-x, 1-111. doi: 10.3310/hta7400.

    PubMed 14636486

  • Bennett SE, Bromley LE, Fisher NM, Tomita MR, Niewczyk P. Validity and Reliability of Four Clinical Gait Measures in Patients with Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):247-252. doi: 10.7224/1537-2073.2015-006.

    PubMed 29070965

  • Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

    PubMed 3809245

  • Burke D, Wissel J, Donnan GA. Pathophysiology of spasticity in stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S20-6. doi: 10.1212/WNL.0b013e31827624a7.

    PubMed 23319482

  • Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

    PubMed 20526405

  • Christine C, Dolk H, Platt MJ, Colver A, Prasauskiene A, Krageloh-Mann I; SCPE Collaborative Group. Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Dev Med Child Neurol Suppl. 2007 Feb;109:35-8. doi: 10.1111/j.1469-8749.2007.tb12626.x. No abstract available.

    PubMed 17370480

  • Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.

    PubMed 16754576

  • Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.

    PubMed 18970977

  • Ertzgaard P, Alwin J, Sorbo A, Lindgren M, Sandsjo L. Evaluation of a self-administered transcutaneous electrical stimulation concept for the treatment of spasticity: a randomized placebo-controlled trial. Eur J Phys Rehabil Med. 2018 Aug;54(4):507-517. doi: 10.23736/S1973-9087.17.04791-8. Epub 2017 Oct 25.

    PubMed 29072043

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343

Questions about this trial

What is this clinical trial studying?

A study testing EXOPULSE Mollii Suit Stimulation in people with Sclerosis, Multiple and MS (Multiple Sclerosis), run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Naji J Riachi, MD (+971 2 314 4444 ext. 2979, nriachi@ssmc.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance using Berg Balance Scale (BBS) (time frame: To be assessed at baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05857280, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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